Neuros Medical gets regulatory OK for implantable device

Neuros Medical Inc., a Willoughby-based medical device company, announced it has received an Investigational Device Exemption approval from the U.S. Food and Drug Administration for its implantable generator.
The device, named Altius, delivers patented high frequency Electrical Nerve Block technology for patients suffering from chronic pain.
Neuros recently announced the results of its long-term pilot study which focused on patients afflicted with chronic amputation pain. Seven out of 9 study subjects, using an external generator, reported significant pain reduction (defined as 50 percent or greater) observed for up to 12 months of evaluation. The study demonstrated no safety issues over the treatment period.
Subjects enrolled in the long-term pilot study will now be able to use the implantable generator.
We are extremely pleased with the IDE approval and look forward to converting the pilot study participants to the Altius implantable device, continuing to provide long-term pain relief to those suffering from chronic amputation pain, said Jon J. Snyder, president and CEO of Neuros Medical.